Department of Endocrinology and Metabolism, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Diabetes Metab J. 2011 Jun;35(3):290-7. doi: 10.4093/dmj.2011.35.3.290. Epub 2011 Jun 30.
To investigate the clinical results of sitagliptin (SITA) and the characteristics of the treatment failure group or of low responders to SITA.
A retrospective study of type 2 diabetic patients reviewed 99 cases, including 12 treatment failure cases, who stopped SITA because of worsening patients' condition, and 87 cases, who continued treatment over five visits (total 9.9±10.1 months) after receiving the prescription of SITA from December 2008 to June 2009. Subjects were classified as five groups administered SITA as an initial combination with metformin (MET), add-on to metformin or sulfonylurea, and switching from sulfonylurea or thiazolidinedione. The changes in HbA1c level from the first to last visit (ΔHbA1c) in treatment maintenance group were subanalyzed.
The HbA1c level was significantly reduced in four groups, including initial coadministration of SITA with metformin (ΔHbA1c=-1.1%, P<0.001), add-on to MET (ΔHbA1c=-0.6%, P=0.017), add-on to sulfonylurea (ΔHbA1c=-0.5%, P<0.001), and switching from thiazolidinedione (ΔHbA1c=-0.3%, P=0.013). SITA was noninferior to sulfonlyurea (ΔHbA1c=-0.2%, P=0.63). There was no significant adverse effect. The treatment failure group had a longer diabeties duration (P=0.008), higher HbA1c (P=0.001) and fasting plasma glucose (P=0.003) compared to the maintenance group. Subanalysis on the tertiles of ΔHbA1c showed that low-response to SITA (tertile 1) was associated with a longer diabetes duration (P=0.009) and lower HbA1c (P<0.001).
SITA was effective and safe for use in Korean type 2 diabetic patients. However, its clinical responses and long-term benefit-harm profile is yet to be established.
研究西他列汀（SITA）的临床效果以及治疗失败组或 SITA 低应答者的特征。
对 2008 年 12 月至 2009 年 6 月期间接受 SITA 处方的 99 例 2 型糖尿病患者进行回顾性研究，其中包括 12 例因病情恶化而停止 SITA 治疗的治疗失败病例，以及 87 例在接受 SITA 治疗后进行了 5 次就诊（总共 9.9±10.1 个月）的病例。将患者分为 SITA 初始联合二甲双胍（MET）、加用 MET 或磺酰脲类药物、以及从磺酰脲类或噻唑烷二酮类药物转换的 5 组。对维持治疗组从第一次就诊到最后一次就诊时的 HbA1c 水平变化（ΔHbA1c）进行亚分析。
4 组患者的 HbA1c 水平均显著降低，包括 SITA 与 MET 初始联合使用组（ΔHbA1c=-1.1%，P<0.001）、加用 MET 组（ΔHbA1c=-0.6%，P=0.017）、加用磺酰脲类药物组（ΔHbA1c=-0.5%，P<0.001）以及从噻唑烷二酮类药物转换组（ΔHbA1c=-0.3%，P=0.013）。SITA 与磺酰脲类药物相比不劣效（ΔHbA1c=-0.2%，P=0.63）。未发现明显的不良反应。与维持治疗组相比，治疗失败组的糖尿病病程更长（P=0.008），HbA1c 和空腹血糖更高（P=0.003）。对 ΔHbA1c 的三分位亚分析表明，SITA 低应答（三分位 1）与糖尿病病程更长（P=0.009）和 HbA1c 更低（P<0.001）相关。
SITA 对韩国 2 型糖尿病患者有效且安全，但尚需确定其临床疗效和长期获益-风险特征。
